Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications
In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.
Ohio doctor gets 7 years in prison for violating Controlled Substances Act
The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.
UPMC settles $38M whistleblower lawsuit for Medicare fraud
Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.
FDA announces new recall of delivery catheters after patient’s death
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls
The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

Society for Cardiovascular Angiography and Interventions (SCAI) is asking its interventional cardiologist members to take action to prevent further cuts in Medicare payments in 2024 by contacting their Congressmen. There were substantial cuts in Centers for Medicare and Medicaid Services (CMS) payments to physicians in 2023 further cuts each year can only be prevented if Congress changes the laws for how CMS pays physicians.

Governors urge Congress to act now on medication shortages, supply chain insecurities

Eleven GOP governors joined together to call for a more transparent drug manufacturing supply chain.

August 31, 2023

AHA shares support of new prior authorization reform in letter to Congress

The American Hospital Association believes the Gold Card Act could help healthcare providers throughout the country avoid "dangerous delays."

August 31, 2023

Former Mayo Clinic researcher gets 18 years in prison for supporting ISIS

The man vowed to conduct "lone wolf" attacks in support of the terrorist group ISIS.

August 28, 2023

Should masks still be required at hospitals? Physicians push for a nuanced approach in face of uncertainty

A team of physicians examined the question of continued masking, urging healthcare leaders to work together in a new commentary in Annals of Internal Medicine.

August 24, 2023

The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval.

August 23, 2023

Lab owner gets 27 years in prison for $463M Medicare fraud scheme

According to the U.S. Department of Justice, LabSolutions took advantage of patients using a telemarketing scheme, with its owner personally pocketing millions in kickbacks.

August 21, 2023

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries.

August 18, 2023

GE Healthcare's Portrait Mobile wireless and wearable monitoring solution

GE HealthCare earns FDA clearance for new remote patient monitoring device

The newly cleared device was designed with patient freedom and flexibility in mind.

August 18, 2023

Around the web

Cardiovascular Business

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

Cardiovascular Business

FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

Cardiovascular Business

The push for an independent cardiology board continues

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.